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An integrated pharmacovigilance model to meet regulatory trends

Hundreds of thousand deaths caused by Adverse Drug reaction are reported yearly across the globe – and the cost to manage the effect of adverse reactions is astronomical*. With that in mind, the imperative to change the pharmacovigilance model is at the forefront of Regulatory agencies agenda.

In recent years, new regulatory requirements around pharmacovigilance have been introduced in all regions. The following three trends represent a major departure from the traditional and more reactive model of pharmacovigilance:

 

1. A shift from a passive to active surveillance

2. A strong emphasis on risk-benefit balance

3. Globalization of pharmacovigilance

 

Above trends bring about several challenges and opportunities that a biopharmaceutical company need to address when building an effective pharmacovigilance system. Explore more in this white paper.

White Paper: An Integrated Pharmacovigilance Model to Meet New Regulatory Trends

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